GlaxoSmithKline plc (GSK, NYSE: GSK) announced that the U.S. Food and Drug Administration (FDA) approved Exdensur (depemokimab) as an add‑on maintenance treatment for severe asthma with eosinophilic phenotype in adult and pediatric patients aged 12 years and older. The drug is the first ultra‑long‑acting biologic enabling twice‑yearly dosing for respiratory diseases with type 2 inflammation.
Regulatory Milestone
Item
Details
Approval Date
17 Dec 2025
Agency
U.S. FDA
Product
Exdensur (depemokimab)
Indication
Add‑on maintenance for severe eosinophilic asthma (age ≥12)
Dosing
Twice yearly (every 26 weeks)
Innovation
First ultra‑long‑acting biologic for type 2 inflammatory respiratory diseases
Mechanism
IL‑5 inhibitor with extended half‑life
Clinical Evidence – SWIFT-1 & SWIFT-2 Phase III Trials
Endpoint
Exdensur (depemokimab)
Placebo (SOC)
Reduction
SWIFT‑1 Annualized Exacerbations
58% reduction
Standard of care
p < 0.001
SWIFT‑2 Annualized Exacerbations
48% reduction
Standard of care
p < 0.001
Treatment Duration
Two doses per year (52 weeks)
—
Sustained efficacy
Safety Profile
Well‑tolerated
Similar rate/severity of side effects
Comparable to placebo
Market Opportunity & Competitive Landscape
Metric
Value
Implication
Severe Asthma Prevalence
25‑30 million patients globally
~50% have eosinophilic phenotype
Biologic Market
$18‑22 billion (2025)
Dominated by anti‑IL‑5/IL‑5R agents (Nucala, Fasenra, Dupixent)
Twice‑Yearly Advantage
Reduces treatment burden vs. monthly/quarterly competitors
First ultra‑long‑acting agent with Q6M dosing
Peak Sales Potential
$3‑5 billion (global estimate)
Captures 15‑20% of severe eosinophilic asthma segment
Pricing Strategy
Premium pricing justified by dosing convenience
Potential for favorable payer negotiations
Strategic Implications
For GSK:Ultra‑long‑acting dosing differentiates Exdensur in crowded IL‑5 market; type 2 inflammation platform can be extended to COPD, eosinophilic esophagitis; builds on respiratory franchise leadership.
For Patients:Twice‑yearly dosing dramatically improves adherence and quality of life; off‑the‑shelf subcutaneous injection simplifies administration vs. infusion‑based therapies.
For Market:First Q6M biologic sets new standard for convenience; SWIFT data demonstrates robust exacerbation reduction; positions GSK to recapture market share from monthly competitors (Nucala, Fasenra).
Forward‑Looking Statements This brief contains forward‑looking statements regarding Exdensur’s commercial launch, market penetration, and label expansions. Actual results may differ due to regulatory feedback, competitive responses, or payer access hurdles.-Fineline Info & Tech
By Fineline Cube 